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The effectiveness and the safety of AMNV in patient with herpes zoster treated with immunosuppressive agents:exploratory Study

The effectiveness and the safety of AMNV in patient with herpes zoster treated with immunosuppressive agents:exploratory Study - SAPPHIRE study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031190208
Enrollment
50
Registered
2020-02-13
Start date
2020-04-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster

Interventions

Study drug (Amenamevir Tablets 200mg) Oral administration of 2 tablets (400mg) once a day after meal for 7-14 days

Sponsors

Imafuku Shinichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients aged >= 20 years old who provide written informed consent to participation in the study. (2) Patients who received immunosuppressive therapy (ex. Chemotherapy, oral steroid, cyclosporine, JAK inhibitor etc. ) for cancer (solid/ blood), transplantation or connective disease. (3)Patients who appeared the rash within 5 days.

Exclusion criteria

Exclusion criteria: (1) Patients has a known hypersensitivity to amenamevir. (2) Patients have been treated with Rifampicin. (3) Patients who are not expected to have an adequate response to oral antiviral medication. (4) Patients have been treated antiviral drugs (except for anti-influenza drugs and ophthalmic agent) or immunoglobulins within 14 days prior to the obtainment of consent. (5) Patients who cannot interrupt everolimus,cyclosporine,sirolimus,tacrolimus during the administration of amenamevir. (6) Patients have been received treatment to Acquired Immune Deficiency Syndrome or Human Immunodeficiency Virus. (7) Female patients who is breastfeeding, pregnant, or plans to become pregnant during the study. (8) Other patients who are considered to be unsuitable for the study by the investigator or subinvestigator.

Design outcomes

Primary

MeasureTime frame
Overall improvement of skin symptoms 7 days after administration

Secondary

MeasureTime frame
(1) 14 days after start of administration, overall improvement of skin symptoms at the end of observation (2) Change of skin condision where all lesions of erythemas/papulae, vesicles/pustules, erosions/ulcers and crust. (3) Time to Complete Crusting (4) Time to Healing (5) Time to Pain Resolution (Pain scales: NRS) (6) The improvement of Quality of life (QOL) (Scale:SF-8)

Contacts

Public ContactShinichi Imafuku

Fukuoka University Hospital

dermatologist@mac.com+81-92-801-1011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026